510(k) K160829 ยท OZX Mycoplasma Pneumoniae Dna Assay System
illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10
| Applicant | Meridian Bioscience, Inc., Cincinnati OH, US |
| Decision | Substantially Equivalent, Jun 13, 2016 |
| Received | Mar 25, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160829
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.